China Human Diploid Cell Hepatitis A Virus Vaccine For Immunization Manufacturer, Supplier, Factory

AIM Honesty Biopharmaceutical Co., Ltd. is a China-based manufacturer and supplier of Human Diploid Cell Hepatitis A Virus Vaccine For Immunization, functioning as a wholly-owned subsidiary of AIM Vaccine Co., Ltd. The company applies human diploid cell culture technology to produce inactivated hepatitis A vaccines that comply with national pharmaceutical manufacturing standards, serving public health systems, healthcare providers, and immunization programs that require a stable supply from a qualified Chinese factory.

A Cell Substrate With Real History

The KMB17 human diploid cell line is not a recent development. It was independently established by the Kunming Institute in 1974 and has since been validated through decades of practical use. For this Human Diploid Cell Based Hepatitis A Vaccine Product, the choice of substrate directly influences both safety and consistency.

Human diploid cells offer a clear advantage over animal-derived cell cultures. They eliminate risks tied to unknown animal pathogens and xenogeneic proteins. The same KMB17 cell matrix has been safely employed worldwide in high-end vaccines, including rabies and varicella preparations, giving procurement teams a familiar reference point when assessing supplier credibility.

The production flow follows a defined sequence:

1. Culture the Lv-8 strain of hepatitis A virus in KMB17 cells
2. Harvest and concentrate the viral suspension through ultrafiltration
3. Purify the material by chromatography
4. Inactivate with formaldehyde solution to obtain the final antigen

Each step is designed to preserve immunogenicity while removing the virus's ability to replicate, a balance that matters greatly to safety reviewers.

The Lv-8 Strain and Its Documented Origin

The Lv-8 strain behind this Human Diploid Cell Hepatitis A Virus Vaccine For Immunization has a traceable background. It was isolated and screened by the Kunming Institute during the 1988 Shanghai hepatitis A outbreak, taken from a typical patient in Lüsi Town, Jiangsu Province. That outbreak affected more than 300,000 people within three months, the largest hepatitis A outbreak recorded globally at the time.

The strain carries traits that manufacturers value: a short replication cycle, high virus yield, stable genetics, and solid immunogenicity. These properties support consistent production results and dependable immune responses across vaccinated groups.

Specifications and Dosing Reference

Shake well before use and administer intramuscularly at the deltoid muscle attachment site on the outer side of the upper arm. For individuals aged 1-15 years, use the children's dosage. For those over 15 years, the adult dosage applies. The two-dose schedule, a primary dose plus a booster at 6 months, supports long-term immune protection.

Safety Data Worth Reviewing

Safety surveillance often decides whether a supplier makes the shortlist. China's National Adverse Events Following Immunization data from 2016 to 2018 offers useful context for this Human Diploid Cell Based Hepatitis A Vaccine Product.

The incidence of adverse reactions per 100,000 doses for inactivated hepatitis A vaccine was 1.6, 1.4, and 1.39 across those three years. Live attenuated hepatitis A vaccine showed rates of 1.87, 1.73, and 2.6 during the same period.

Several practical points stand out for the inactivated formulation:

1. No contraindication for immunocompromised individuals, unlike live attenuated alternatives
2. Shorter interval (1 month versus 3 months) when given with human immunoglobulin
3. No restriction during hepatitis A outbreaks, making it suitable for outbreak response
4. Does not replicate in the liver, reducing hepatic safety concerns

These features matter for immunization programs serving diverse populations, including people with chronic liver disease or compromised immune function.

How Long Does Protection Last

Duration of protection shapes long-term planning for public health budgets. Antibodies induced by inactivated hepatitis A vaccines generally persist for more than 25 years, with some studies inferring protection beyond 40 years. For adults receiving a single dose, data show protection lasting 11 years, a useful attribute for travelers needing immediate immune protection.

This profile compares well with live attenuated vaccines, where antibodies typically last 10-15 years. For national immunization programs and healthcare systems seeking cost-effective solutions, the inactivated vaccine's extended protection window reduces the need for frequent revaccination.

Antibody Response and Clinical Performance

This Hepatitis A Virus Vaccine With High Antibody Response demonstrates solid immune effects in both adults and children. Clinical data show the seroconversion rate is similar to imported hepatitis A inactivated vaccines, while the geometric mean titer (GMT) of antibody is better than that of imported hepatitis A inactivated vaccines.

In plain terms, the vaccine achieves comparable rates of seroprotection and induces higher antibody levels on average, which may contribute to more robust and durable immunity.

Quality, Approvals, and Market Track Record

AIM Action Biopharmaceutical Co., Ltd. holds four approval document numbers for its inactivated hepatitis A vaccine: single vial for adults, single vial for children, pre-filled syringe for adults, and pre-filled syringe for children. This range satisfies differentiated needs across provinces and healthcare settings.

Since market launch, the Inactivated Hepatitis A Vaccine has kept a 100% passing rate in batch release inspections conducted by the National Institutes for Food and Drug Control for eight consecutive years. In 2025, the company achieved annual sales exceeding RMB 100 million for its hepatitis A vaccine products.

The manufacturing facility operates under GMP certification and follows China's national pharmaceutical manufacturing quality management standards. Recognition includes Contract-Observing Trustworthy Enterprise and Top 10 Scientific and Technological Innovation Enterprises.

Who Benefits Most

This Hepatitis A Virus Vaccine For Routine Immunization Programs serves several populations:

Healthcare providers and national immunization programs need reliable supply for childhood vaccination schedules. The inactivated vaccine can be given as early as 12 months of age, offering earlier protection than live attenuated alternatives that start at 18 months.

Travel medicine clinics serving individuals visiting hepatitis A-endemic regions benefit from the rapid immune response and long-term protection profile. The 2-dose series can be completed before travel, with the first dose providing adequate short-term protection.

Occupational health programs for healthcare workers, sewage treatment personnel, and food handlers value the safety profile and fewer contraindications compared to live vaccines.

Why Inactivated Formulation Leads Globally

Global usage patterns reveal a clear preference. Inactivated hepatitis A vaccines are widely used worldwide and represent the most commonly used hepatitis A vaccines globally. Live attenuated vaccines remain primarily used in China and India.

The WHO recommends inactivated hepatitis A vaccines, and many countries have incorporated them into national immunization schedules. The global market continues to grow, driven by government-led immunization initiatives, increasing international travel, and rising awareness of vaccine-preventable diseases.

AIM Vaccine Co., Ltd. is among the leading vaccine companies in China, covering the full value chain from research and development to manufacturing and commercialization. The company operates four licensed vaccine manufacturing facilities and has commercialized products across six disease areas.

Handling and Supply Practicalities

Vaccine procurement involves logistics beyond clinical efficacy. This Inactivated HAV Vaccine For Pediatric And Adult Immunization demonstrates good stability in storage and transportation. Its liquid formulation, with no reconstitution required for pre-filled syringes, simplifies administration and lowers the risk of handling errors.

For immunization programs requiring large-scale distribution, the availability of both vial and pre-filled syringe presentations allows flexibility based on infrastructure and training levels at different healthcare settings.

Frequently Asked Questions

Q: What distinguishes inactivated hepatitis A vaccine from live attenuated vaccine?

A: Inactivated vaccines contain no live virus particles and do not replicate in cells, resulting in a lower incidence of adverse reactions. Live attenuated vaccines contain weakened live virus with potential risk of virulence reversion. Inactivated vaccines also have fewer contraindications, are approved for immunocompromised individuals, and provide protection lasting more than 25 years compared to 10-15 years for live attenuated vaccines.

Q: Can this vaccine be used during hepatitis A outbreaks?

A: Yes. Unlike live attenuated vaccines, which are not recommended during hepatitis A outbreaks, inactivated hepatitis A vaccines have no such restriction and can be used for outbreak response.

Q: What is the vaccination schedule?

A: The schedule involves two doses: a primary immunization followed by a booster 6 months later. Children aged 1-15 years receive 0.5ml per dose (320 EU antigen). Adults over 15 years receive 1.0ml per dose (640 EU antigen).

Q: How does this vaccine perform compared to imported alternatives?

A: The vaccine demonstrates a seroconversion rate similar to imported hepatitis A inactivated vaccines, while the geometric mean titer of antibody is better than that of imported hepatitis A inactivated vaccines.

Q: What is the manufacturing origin of this vaccine?

A: AIM Honesty Biopharmaceutical Co., Ltd. is a China-based manufacturer. The vaccine uses the KMB17 human diploid cell line and Lv-8 virus strain, with production facilities located in China.

Q: Is the vaccine suitable for immunocompromised individuals?

A: Yes. Inactivated hepatitis A vaccines have no contraindication for people with immunodeficiency or impaired immune function, whereas live attenuated vaccines are contraindicated for such individuals.

Summary

The Human Diploid Cell Hepatitis A Virus Vaccine For Immunization from AIM Action Biopharmaceutical Co., Ltd. offers a mature, human diploid cell-based solution for hepatitis A prevention. Its documented safety profile, extended duration of protection, and flexible dosing options for pediatric and adult populations address the core requirements of immunization programs, healthcare providers, and procurement teams evaluating hepatitis A vaccine suppliers. The combination of the Lv-8 strain's documented origin, KMB17 cell line technology, and consistent batch release performance provides a foundation for reliable vaccine supply from a qualified Chinese manufacturer.

Structure of hepatitis A virus